Drug product
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
D-0219-2026
Product summary
- Event
- Event 97957
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 4800 54-count bottles
- Official record key
drug-enforcement:D-0219-2026
Official wording
Reason: Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Code information: Lot # F2400244, Exp Date: 10/31/2026
Distribution pattern: Distributed Nationwide
Derived failure modes
-
Unknown
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.